MalfunctionEYI
NONE
Received Apr 16, 2014
Report 1419727-2014-00001 · MDR key 3856684
Device
Generic name
None
Product problems
- Break
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
(B)(4).
Additional Manufacturer Narrative
THIS IS A RESPONSE TO THE USER FACILITY'S INITIAL REPORT. THE DEVICE WAS RETURNED AND VISUALLY INSPECTED. OUR INVESTIGATION REVEALED THAT THE MOLDING PROCESS RESULTED IN AN INCOMPLETE DEVICE. ALTHOUGH EACH OF THESE MOLDED DEVICES COMPLETES TWO QUALITY ASSURANCE CHECKS INCLUDING 100% VISUAL INSPECTION, THIS DEVICE WAS NOT DETECTED PRIOR TO SHIPMENT. WE HAVE HAD NO OTHER REPORTS OF THIS NATURE AND BELIEVE IT TO BE AN ISOLATED INCIDENT.